Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Medical Writer - CMC Focus based in United States . This is a senior regulatory writing role focused on creating high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions. You will take ownership of complex, submission-level documents while contributing to engagements across different development programs and therapeutic areas. The role combines hands-on authorship with project leadership, requiring strong scientific judgment and an understanding of global regulatory expectations. You will work across areas such as biologics, vaccines, gene and cell therapy, small molecules, manufacturing, analytical development, and stability. The position offers significant influence over document quality, submission strategy, timelines, and successful health authority interactions. You will also mentor colleagues, provide subject matter guidance, and help strengthen regulatory writing practices across the organization. The environment is collaborative, flexible, and globally connected, with the opportunity to contribute to therapies intended to improve patients' lives. Accountabilities: - Regulatory Document Authoring: Lead and contribute to the development of high-quality regulatory documents across client engagements, with a particular focus on CMC documentation and submission-level materials. - CMC Submission Leadership: Own and author key sections of regulatory submissions, including Module 3, such as Modules 3. 2. S and 3. 2. P, and Module 2. 3. - Project Leadership: Lead project teams and coordinate contributors toward shared objectives while maintaining document quality, timelines, and budget expectations for complex engagements.

- Scientific Synthesis: Integrate and synthesize information from multiple data sources and documents to create clear, accurate, and scientifically sound regulatory content and summary reports. - Quality & Review: Provide expert guidance on document preparation, review, comment resolution, incorporation of feedback, and finalization of submission-ready materials. - Regulatory Strategy: Apply knowledge of regulatory authority guidelines, development phases, and global regulatory pathways to anticipate how writing practices and document decisions may affect regulatory review and acceptance. - Mentoring & Knowledge Sharing: Coach and mentor other writers, promote effective communication and working practices, and transfer regulatory writing expertise to strengthen capabilities across the wider team. - Client Collaboration: Build professional relationships with clients, support ongoing business relationships, maintain current industry knowledge, and contribute to effective delivery across engagements. Requirements - Education: Bachelor's degree or higher, with a scientific discipline strongly preferred. - Regulatory Writing Experience: 7+ years of regulatory writing experience, specifically involving Chemistry, Manufacturing, and Controls documentation. - Therapeutic & Technical Expertise: Experience across areas such as vaccines, gene and cell therapy, biologics, small molecules, manufacturing, analytical development, or stability. - Submission Experience: Proven experience working on regulatory submissions such as NDAs, INDs, BLAs, or IMPDs, including document-lead responsibilities for submission-level materials. - CMC Expertise: Strong experience authoring and leading Module 3 documentation, including Modules 3. 2. S and 3. 2. P, as well as Module 2. 3. - Regulatory Knowledge: Strong understanding of global health authority requirements, regulatory guidelines, development phases, and different regulatory pathways. - Technical Writing Skills: Intermediate Microsoft Word proficiency, including editing tools, table creation and modification, figure insertion, and document management techniques.

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